Apply for a license to trade in raw materials

Source: BUS Rheinland-Pfalz

The handling of precursors that can potentially be converted into drugs is subject to strict controls, especially if they are category 1 precursors that can be used to produce drugs with a high potential for dependence and abuse.

You require a permit for any handling of these precursors. This is the case if you

possess
manufacture
process
store them
trade with them
arrange transactions with them
carry out drop shipments, even if the raw materials do not touch the territory of the European Union (EU)
import into the EU
export from the EU

If you already have a permit to handle precursors but wish to change it, you must apply for a new permit. This may be the case if

another basic substance is added
a new process is to be included
the location of your premises where you carry out the operations changes.

If the responsible representative or the name of the company changes, you must also inform the BfArM.

You can submit all applications informally in writing.

You can apply online or informally in writing to the BfArM for a permit to handle category 1 precursors.

Apply for a permit online:

Go to the website of the federal portal and call up the online application. This will guide you step by step through the necessary information, which you can enter electronically.
- You will need the following for the application:
  - an Elster company account
  - an Elster certificate.
Upload the required documents as a PDF, PNG or JPEG file with a maximum size of 10 megabytes each and send the application.
If any of your details or documents are incomplete, you will receive a request to submit them within a deadline set by the BfArM.
If you are granted a license, the BfArM will send you the license certificate by post together with a notification of fees.

Apply for a permit informally in writing:

Draw up an application with all the required information, print it out and sign it.
Send your informal application to the BfArM by post.

If any of your details or documents are incomplete, you will receive a request to submit them within a deadline set by the BfArM. If you are granted authorization, the BfArM will send you the authorization certificate by post together with a fee notice.

Your complete details:
- Name
- your address
- telephone number
- Fax number, if available
- e-mail address
Designation and Combined Nomenclature (CN) code of the required raw materials and their salts
For mixtures:
- the name of the mixture
- the name and CN codes of all the basic substances contained in the mixture
- an indication of the maximum possible content of such basic substances in the mixture
description of the operations envisaged, for example
- Trade in the European Union
- further processing
- import
- export
- Brokerage
- Intermediary transactions
completed declaration form for the appointment of the responsible agent(s)
current police clearance certificate of the appointed responsible agent(s)
certified extract
- from the commercial register or
- certified copy of the business registration

Emission: 110,00 EUR
Payment in advance: no
https://www.gesetze-im-internet.de/bmgbgebv/index.html
For a new or change application per raw material and per operating site

Emission: 55,00 EUR
Payment in advance: no
https://www.gesetze-im-internet.de/bmgbgebv/index.html
For a new or change application for a basic substance for scientific or analytical purposes without a commercial purpose per basic substance and per operating site

The application for a license must be submitted before you start working with category 1 precursors.

If any of your details or documents in your application for authorization are incomplete, you will be asked to submit them within a deadline set by the BfArM.

If the name or legal form of your company changes, if you appoint a new responsible representative or if their name or address changes, you must inform the BfArM within 10 working days by e-mail or in writing.

Period of Validity: 3 Years
The BfArM can either limit the validity of the license to a maximum period of 3 years or require you to prove at regular intervals of no more than 3 years that you still meet the requirements for the license.

Apply for a license to trade in raw materials

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